New Treatment Perspectives in Eating Disorders: the Efficacy of Non-invasive Brain-directed Treatment

Mariella Enoc

Status: Unknown

Conditions: Eating Disorders; Anorexia Nervosa; Binge Eating Disorder

Treatments: Device: BED Sham tDCS; Device: BED Active tDCS; Device: AN Sham tDCS; Device: AN Active tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02382497

763_OPBG_2014

Details and patient eligibility

About

The present study grounds on the possible role of hemispheric lateralization in Eating disorders (ED): specifically, hyperactivity of the right frontal regions in Anorexia Nervosa (AN), and hypoactivity of the right frontal regions in Binge Eating Disorder (BED) and food craving behaviors.

Therefore, the investigators hypothesized that active excitatory tDCS over left prefrontal cortex (PFC) (Anode left/cathode right) may aid in altering/resetting inter-hemispheric balance in AN patients, re-establish control over eating behaviors. On the contrary, active excitatory tDCS over right PFC (Anode right/cathode left) may aid in altering/resetting inter-hemispheric balance in BED patients and people with frequent food cravings, decreasing cravings/appetite binge eating behaviors.

Full description

The study design is randomized stratified, double blind, add-on, placebo-controlled.

A group of children and adolescents with AN will be selected and randomly assigned to two different conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS).

Similarly, a group of children and adolescents with Over-weight/Obesity (OW/OB) and BED will be selected and assigned with randomized stratified sampling to the following conditions: treatment "as usual" plus experimental treatment (active tDCS); treatment "as usual" plus placebo treatment (sham tDCS).

In this project, the investigators will work to understand whether a brain-based treatment, with the use of tDCS, can improve the outcome of patients with eating disorders.

The investigators will test whether tDCS treatment produces improvements in under-eating and over-eating diseases, such us AN and OW/OB with BED and food craving.

Our overarching goal is to provide a scientific foundation for devising new rehabilitation strategies in ED.

Enrollment: 160 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Under-weight (BMI less than 5th percentile)1 with Clinical diagnosis of AN as described in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Over-weight/Obesity (OW/OB) (BMI above the 85th percentile)1 with diagnosis of BED, or with food craving behaviors
• Ability to give informed consent under parents' surveillance and guidance

Exclusion criteria

• Having a comorbidity with an important medical condition;
• Having neurological diseases
• Having Epilepsy o family history of epilepsy
• Pregnant or planning to become pregnant;
• Suicide risk;
• Receiving counseling or psychological therapies during the study;
• Receiving a treatment for an eating disorder in the previous three months before the baseline screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 4 patient groups

AN Active tDCS

Experimental group

Description:

Treatment "as usual" plus experimental treatment

Treatment:

Device: AN Active tDCS

AN Sham tDCS

Sham Comparator group

Description:

Treatment "as usual" plus placebo treatment

Treatment:

Device: AN Sham tDCS

BED Active tDCS

Experimental group

Description:

Treatment "as usual" plus experimental treatment

Treatment:

Device: BED Active tDCS

BED Sham tDCS

Sham Comparator group

Description:

Treatment "as usual" plus placebo treatment

Treatment:

Device: BED Sham tDCS